Clinical Quality & Risk Manager
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Kuala Lumpur • 🇲🇾 Malaysia
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Overseeing quality assurance and risk management activities for clinical trials within the CDC.
- Ensuring compliance with regulations, international guidelines and Novo Nordisk policies and processes.
- Identifying potential risks, implementing mitigation strategies, and promoting continuous improvement in quality and risk management.
- Perform ongoing country-level quality risk assessments and develop actionable mitigation plans.
- Serve as the primary point of contact for CDC management and therapeutic area units on quality risk management and mitigation.
- Identify emerging risks using process analytics and digital tools, turning data into actionable insights.
- Drive strategic quality planning to align clinical quality goals with organizational objectives, regulatory standards, and compliance requirements.
- Provide data-driven monitoring of quality and compliance, identify trends, conduct root cause analyses, and implement CAPAs to improve data quality.
- Provide quality oversight across clinical program lifecycles including audits, inspections, serious breach resolution and lead change management to secure stakeholder support.
- Coordinate SMEs for local training, champion innovative centralized solutions, and foster cross-functional collaboration.
Requirements
- Bachelor's degree in Life Sciences or related field minimum, master’s preferred.
- 5+ years of relevant experience in clinical operations or quality role in the pharmaceutical industry or CRO.
- Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements and internal SOPs.
- Broad understanding of clinical R&D, global regulations, and regulatory submission/inspection management.
- Strong skills in GCP, clinical development, and quality management system.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible working arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurancerisk managementclinical trialsdata analyticsroot cause analysisCAPAGCPclinical developmentquality management systemregulatory compliance
Soft skills
strategic planningcross-functional collaborationcommunicationproblem-solvingleadership